Ultrasound Evaluation of the IVC in Addition to Clinical Assessment to Guide Decongestion in ADHF

NCT ID: NCT03140566

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-03
• Study Completion Date: 2019-09-24

Brief Summary

CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial. The objective is to test whether evaluation of the inferior vena cava diameter in addition to clinical assessment is superior compared to clinical assessment alone with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Detailed Description

Only limited evidence is available on the best method to monitor and guide decongestion in acute decompensated heart failure. Therefore, no specific guideline recommendations are made in this regard. It is unknown whether an objective congestion marker can be used to guide decongestion or such marker is only of prognostic value by identifying high-risk patients with an advanced disease state.

CAVA-ADHF is designed as prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial and aims to demonstrate effectiveness of inferior vena cava (IVC)-guided decongestion, its feasibility, and to estimate effect size and variability of clinical endpoints following the intention-to-treat principle.

After inclusion and exclusion criteria have been checked patients will be randomized:

Experimental intervention: Decongesting treatment guided by clinical assessment and ultrasound evaluation of the IVC diameter. Decongestion should lead to a maximal IVC diameter ≤2.1 cm and IVC collapsibility index >50% in addition to relief of symptoms and signs of congestion before discharge.

Control intervention: Decongesting treatment guided by clinical assessment alone. The IVC ultrasound evaluation is performed, but results are not reported to treating physicians.

Trial intervention will end with discharge from the index hospitalization. Patients will be followed-up for 180 to 210 days after randomization.

The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Clinical assessment plus IVC diameter

Decongesting treatment guided by clinical assessment and ultrasound evaluation of the inferior vena cava diameter

Group Type: EXPERIMENTAL

Ultrasound evaluation of the inferior vena cava diameter

Intervention Type: DIAGNOSTIC_TEST

Treatment will be guided by clinical assessment and ultrasound evaluation of the inferior vena cava (IVC) diameter. Decongestion should lead to maximal IVC diameter ≤2.1 cm and IVC collapsibility index \>50% in addition to relief of symptoms and signs of congestion before discharge.

Clinical assessment only

Decongesting treatment guided by clinical assessment alone

Group Type: SHAM_COMPARATOR

Sham ultrasound evaluation of the inferior vena cava diameter

Intervention Type: DIAGNOSTIC_TEST

Teatment guided by clinical assessment alone. Decongestion should lead to relief of symptoms and signs of congestion before discharge. IVC ultrasound evaluation is performed, but results are not reported to treating physicians.

Interventions

Ultrasound evaluation of the inferior vena cava diameter

Treatment will be guided by clinical assessment and ultrasound evaluation of the inferior vena cava (IVC) diameter. Decongestion should lead to maximal IVC diameter ≤2.1 cm and IVC collapsibility index \>50% in addition to relief of symptoms and signs of congestion before discharge.

Intervention Type: DIAGNOSTIC_TEST

Sham ultrasound evaluation of the inferior vena cava diameter

Teatment guided by clinical assessment alone. Decongestion should lead to relief of symptoms and signs of congestion before discharge. IVC ultrasound evaluation is performed, but results are not reported to treating physicians.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Hospitalization for ADHF with dyspnea ≥NYHA III, peripheral edema, and pulmonary congestion (rales on auscultation or pulmonary vascular congestion on chest radiograph)
• Age ≥18 years
• NT-proBNP >300 ng/l within 24 h after admission
• Sufficient ultrasound visualization to evaluate IVC
• IVCmax >2.1 cm and IVCCI ≤50 % in the baseline assessment within 24 h after admission
• Capability to sign informed consent personally

Exclusion Criteria

• Cardiogenic shock with systolic blood pressure <90 mmHg plus end-organ hypoperfusion
• ADHF due to significant arrhythmias
• Severe pulmonary disease as primary cause of dyspnea
• Simplified Modification of Diet in Renal Disease estimated glomerular filtration rate <30 ml/min/1.73 m²
• Need for non-invasive or invasive ventilation support at baseline
• Pregnancy
• Participation in another interventional trial regarding heart failure treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

University of Luebeck

OTHER

Sponsor Role: lead

Responsible Party

Holger Thiele

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitäres Herzzentrum Lübeck

Lübeck, , Germany

Countries

Germany

References

Jobs A, Rausch TK, Konig IR, Vonthein R, Devendra A, Schafer J, Nauck M, Eitel I, Stiermaier T, Laugwitz KL, Ledwoch J, Valentova M, von Haehling S, Stork S, Arnold N, Karakas M, Westermann D, Lenz T, Gori T, Edelmann F, Seppelt P, Felix SB, Lutz M, Hedwig F, Akin I, Scherer C, Desch S, Thiele H; CAVA-ADHF-DZHK10 Investigators. Inferior Vena Cava Ultrasound to Guide Decongestion in Acute Decompensated Heart Failure: A Randomized Controlled Trial. JACC Heart Fail. 2025 Sep 9;13(10):102578. doi: 10.1016/j.jchf.2025.102578. Online ahead of print.

Reference Type: DERIVED

PMID: 40929999 (View on PubMed)

Other Identifiers

CAVA-ADHF-DZHK10

Identifier Type: -

Identifier Source: org_study_id